Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1385](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1385) → HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic # HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic _Ophthalmic · 21 CFR 886.1385 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK ## Overview - **Product Code:** HJK - **Device Name:** Lens, Contact, Polymethylmethacrylate, Diagnostic - **Regulation:** [21 CFR 886.1385](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1385) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 41) Showing 20 most recent of 41 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K201909](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K201909.md) | RxSight Contact Lens | Rxsight, Inc. | Sep 10, 2020 | SESE | | [K173944](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K173944.md) | Endocular Viewing Lenses and Silicone Ring | Phakos | Oct 25, 2018 | SESE | | [K151961](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K151961.md) | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | Aug 18, 2015 | SESE | | [K142715](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K142715.md) | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | Dec 16, 2014 | SESE | | [K051630](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K051630.md) | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | Jun 29, 2005 | SESE | | [K051103](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K051103.md) | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | Jun 7, 2005 | SESE | | [K050623](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K050623.md) | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | Volk Optical, Inc. | Mar 28, 2005 | SESE | | [K033950](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K033950.md) | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | Dutch Ophthalmic Research Center (D.O.R.C.) | Feb 20, 2004 | SESE | | [K030054](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K030054.md) | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Fci Ophthalmics, Inc. | Feb 26, 2003 | SESE | | [K023221](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K023221.md) | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | Oct 11, 2002 | SESE | | [K022413](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K022413.md) | LUNEAU 3 MIRROR LENS | Luneau SA | Sep 24, 2002 | SESE | | [K014170](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K014170.md) | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | Mar 4, 2002 | SESE | | [K012096](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K012096.md) | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | Aug 24, 2001 | SESE | | [K971853](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K971853.md) | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | Aug 6, 1997 | SESE | | [K933976](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K933976.md) | MANDELKORN SUTURE LYSIS LENS | Ocular Instruments, Inc. | Nov 8, 1994 | SESE | | [K933264](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K933264.md) | RITCH NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | Oct 31, 1994 | SESE | | [K940107](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K940107.md) | VIRECTOMY LENS | Visionary Technologies of Miami, Inc. | Sep 6, 1994 | SESE | | [K943125](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K943125.md) | QUADRASPHERIC FUNDUS LENS | Volk Optical, Inc. | Sep 2, 1994 | SESE | | [K941420](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K941420.md) | 50 DEGREE HRI PRISM LENS | Ocular Instruments, Inc. | Aug 29, 1994 | SESE | | [K914051](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K914051.md) | PEDIATRIC VITRECTOMY LENS SET | Ocular Instruments, Inc. | Dec 9, 1991 | SESE | ## Top Applicants - Ocular Instruments, Inc. — 25 clearances - Volk Optical, Inc. — 4 clearances - American Medical Devices, Inc. — 1 clearance - Concept, Inc. — 1 clearance - Dutch Ophthalmic Research Center (D.O.R.C.) — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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